510(k) · Cleared

Cleared

Sinclair Wound and Skin Emulsion

K024367510(k) TraditionalCleared Jul 28, 2003209-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sinclair Pharmaceuticals, Ltd. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Cleared on Jul 28, 2003 as substantially equivalent to K964240 (Medix Pharmaceuticals Americas, Inc., 1997) and 1 other predicate after a 209-day review. Its family tree reaches back 1 generation to 1996. 67 later devices descend from it.

Decided: Jul 28, 2003
Review: 209 days
Class: Class U
Product code: MGQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K961758 (1996). 2 ancestors in all. 67 later devices descend from it, 10 citing it directly.

By dateBy generation

Root · 1 generation backK961758 Carasyn Hydrogel Wound ProductsCarrington Laboratories, Inc. · 1996
This deviceK024367 Sinclair Wound and Skin EmulsionSinclair Pharmaceuticals, Ltd. · 2003
Descendant · cites it directly · 44 of its ownK041342 Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005
Descendant · cites it directly · 17 of its ownK102945 Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011
Descendant · cites it directly · 16 of its ownK052643 EpiceramCeragenix Corporation · 2006
Descendant · 2 generations on · 11 of its ownK123071 Vashe Skin and Wound HydrogelPuricore, Inc. · 2013
Descendant · 3 generations on · 10 of its ownK141863 Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015

Showing 5 of 67 descendants. See all descendants

Descendants cleared per year

2005high 8 (2009) · low 0 (2019)2026

Most influential descendants

Showing 5 of 67 · See all

K041342Impruv a.I. Cream Wound and Skin EmulsionStiefel Laboratories, Inc. · 2005 · cites it directly44descendants
K102945Pediacyn Atopic Dermatitis HydrogelOculus Innovative Sciences, Inc. · 2011 · cites it directly17descendants
K052643EpiceramCeragenix Corporation · 2006 · cites it directly16descendants
K123071Vashe Skin and Wound HydrogelPuricore, Inc. · 2013 · 2 generations on11descendants
K141863Puricore Wound Hydrogel Spray DressingPuricore, Inc. · 2015 · 3 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961758	Carasyn Hydrogel Wound Products	Carrington Laboratories, Inc.	1996	—
0 (this device)	K024367	Sinclair Wound and Skin Emulsion	Sinclair Pharmaceuticals, Ltd.	2003	—
+1	K041342	Impruv a.I. Cream Wound and Skin Emulsion	Stiefel Laboratories, Inc.	2005	—
+1	K102945	Pediacyn Atopic Dermatitis Hydrogel	Oculus Innovative Sciences, Inc.	2011	—
+1	K052643	Epiceram	Ceragenix Corporation	2006	—
+2	K123071	Vashe Skin and Wound Hydrogel	Puricore, Inc.	2013	—
+3	K141863	Puricore Wound Hydrogel Spray Dressing	Puricore, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2007	1	0
2008	5	0
2009	8	0
2010	4	0
2011	6	0
2012	6	0
2013	4	0
2014	1	0
2015	8	0
2016	4	0
2017	5	0
2018	2	0
2024	4	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K024367, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K964240	Biafine Wound Dressing Emulsion Summary page 1 …Biologic E 3. Devices to Which New Device is Substantially Equivalent: Biafene Wound Dressing Emulsion (Radiodermatitis Emulsion) in 5 10(k) K964240, from Medix Pharmaceuticals Americas Inc. and CarrasynB Hydrogel Wound Dressing 510(k) K961758, which i…	Medix Pharmaceuticals Americas, Inc.	1997	—
*	K961758	Carasyn Hydrogel Wound Products Summary page 1 …g Emulsion (Radiodermatitis Emulsion) in 5 10(k) K964240, from Medix Pharmaceuticals Americas Inc. and CarrasynB Hydrogel Wound Dressing 510(k) K961758, which is also marketed under the name RadiaCare Gel Hydrogel Wound Dressing. 4. Device Description: S…	Carrington Laboratories, Inc.	1996	—

Also cleared against K964240: 12 other devices →

What descends from it? (67)

See all 67

10 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K041342	Impruv a.I. Cream Wound and Skin Emulsion	Stiefel Laboratories, Inc.	2005	44
K102945	Pediacyn Atopic Dermatitis Hydrogel	Oculus Innovative Sciences, Inc.	2011	17
K052643	Epiceram	Ceragenix Corporation	2006	16
K060272	Locobase Wound and Skin Emulsion	Ferndale Laboratories, Inc.	2007	10
K050158	Sinclair Seborrhea Emulsion	Sinclair Pharmaceuticals, Ltd.	2006	9
K083024	Hylatopic Emollient Foam	Collegium Pharmaceutical Incorporated	2009	8
K071483	Tetrix Cream	Coria Laboratories, Ltd.	2008	2
K152533	Xonrid Gel	Helsinn Healthcare SA	2016	0
K093156	Pruclair Nonsteroidal Cream	Prugen IP Holdings, Inc.	2010	0
K092297	Eletone Cream	Ferndale Pharma Group, Inc.	2009	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K041342 (Stiefel Laboratories, Inc., 2005) has gone furthest, with 44 descendants of its own.
12 other devices also cite its predicate K964240.

How does its category compare?

All MGQ devices

MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGQ

1in 2017

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MGQ

Too few MGQ 510(k)s in any year since 2007 to give a median.

Recalls per year · MGQ

4in 2014

2007high 4 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MGQ

5in 2025

2007high 11 (2024) · low 0 (2008)2025

MAUDE reports naming product code MGQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	0	1
2008	0	—	0	0
2009	1	—	0	2
2010	0	—	0	3
2011	0	—	0	5
2012	0	—	0	1
2013	0	—	0	4
2014	0	—	4	10
2015	0	—	0	3
2016	0	—	0	4
2017	1	—	0	6
2018	0	—	0	2
2019	0	—	0	2
2020	0	—	0	6
2021	0	—	0	1
2022	0	—	0	0
2023	0	—	0	6
2024	0	—	0	11
2025	0	—	0	5
2026	0	—	0	—

What is it indicated for?

FOR TOPICAL DERMATOLOGICAL USE ONLY Description Rx Product: Under the supervision of a healthcare professional, Sinclair Wound and Skin Emulsion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. Sinclair Wound and Skin Emulsion may be used to relieve the pain of first and second degree burns. Sinclair Wound and…

Read the full statement (176 words)

FOR TOPICAL DERMATOLOGICAL USE ONLY

Description Rx Product:

Under the supervision of a healthcare professional, Sinclair Wound and Skin Emulsion is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. Sinclair Wound and Skin Emulsion may be used to relieve the pain of first and second degree burns. Sinclair Wound and Skin Emulsion helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Directions For Use (Rxand OTC):

Apply Sinclair Wound and Skin Emulsion to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover Sinclair Wound and Skin Emulsion with a dressing of choice.

Description OTC Product:

Sinclair Wound and Skin Emulsion helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. Sinclair Wound and Skin Emulsion may also be used to soothe minor burns including sunburn.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024367 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024367: Sinclair Wound and Skin Emulsion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024367

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026